Baxter Recalls Almost 600,000 Units of Saline Solution

Baxter Healthcare has voluntarily recalled nearly 600,000 units of 0.9% sodium chloride injection 500 ml over worries about sterility, according to enforcement records of the US Food and Drug Administration (FDA). It is the sixth such recall of saline solution products by Baxter in the past 15 months.

“Complaints were receive(d) of missing closures and/or leaks which may compromise product sterility,” stated an FDA enforcement report about the latest recall, which Baxter initiated on March 18.

The intravenous saline solution units in question were manufactured at Baxter’s facility in Marion, North Carolina. They constituted 3 lots numbered C929844, C926873, and C928630.

Baxter recalled five other saline solution products in 2014:

 

0.9% Sodium Chloride Product*

Date Recall Initiated

Product Quantity

Reason for Recall

500 ml container

July 30, 2014

157,080 containers

Lack of assurance of sterility

50 ml bag/100 ml bag

July 11, 2014

217,536 bags/161,760 bags

Presence of particulate matter

100 ml single-dose container bag

July 11, 2014

390,560 bags

Presence of particulate matter

1000 ml container

May 12, 2014

4,200 containers

Presence of particulate matter

1000 ml bottle for irrigation

April 21, 2014

211,752 bottles

Presence of particulate matter

*for intravenous use unless otherwise noted

Source: US Food and Drug Administration

Hospitals and clinicians have faced a shortage of 0.9% sodium chloride injection since January 2014, according to the FDA. The agency said that increased demand during the 2013-2014 influenza season may have helped create the shortage. To meet the need, the FDA last year allowed manufacturers such as Baxter to temporarily distribute unapproved saline solution in the United States from their overseas manufacturing plants.

References
SOURCE:

Baxter Recalls Almost 600,000 Units of Saline Solution. Medscape. Apr 08, 2015.

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